A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
Summary
This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.
Timeline
- Start
- 2017-03-02
- Primary completion
- 2020-10-06
- Completion
- 2020-10-30
Outcome
Met primary endpoint
registry Phase 2 Bardoxolone Methyl; p <0.0001; LS Mean change from baseline 13.37 (95% CI 10.48 to 16.27) NCT03019185 ↗
registry Phase 3 Placebo vs Phase 3 Bardoxolone Methyl; p <0.0001; LS Mean difference (Net) 9.49 (97.5% CI 5.38 to 13.60) NCT03019185 ↗
registry Phase 3 Placebo vs Phase 3 Bardoxolone Methyl; p = 0.0005; LS Mean difference (Net) 7.65 (95% CI 3.41 to 11.89) NCT03019185 ↗
paper Patients randomized to bardoxolone methyl experienced preservation in eGFR relative to placebo at 48 and 100 weeks PMID 36411058 ↗
release “At both time, significant improvements in eGFR were observed in bardoxolone methyl group relative to the placebo group” kyowakirin.com ↗
Publications
- Warady BA, Pergola PE, Agarwal R, Andreoli S, Appel GB, Bangalore S, Block GA, Chapman AB, Chin MP, Gibson KL, Goldsberry A, Iijima K, Inker LA, Kashtan CE, Knebelmann B, Mariani LH, Meyer CJ, Nozu K, O'Grady M, Rheault MN, Silva AL, Stenvinkel P, Torra R, Chertow GM. Effects of Bardoxolone Methyl in Alport Syndrome. Clin J Am Soc Nephrol. 2022 Dec;17(12):1763-1774. doi: 10.2215/CJN.02400222. Epub 2022 Nov 21.
- Chertow GM, Appel GB, Andreoli S, Bangalore S, Block GA, Chapman AB, Chin MP, Gibson KL, Goldsberry A, Iijima K, Inker LA, Knebelmann B, Mariani LH, Meyer CJ, Nozu K, O'Grady M, Silva AL, Stenvinkel P, Torra R, Warady BA, Pergola PE. Study Design and Baseline Characteristics of the CARDINAL Trial: A Phase 3 Study of Bardoxolone Methyl in Patients with Alport Syndrome. Am J Nephrol. 2021;52(3):180-189. doi: 10.1159/000513777. Epub 2021 Mar 31.
- Kashtan CE, Gross O. Clinical practice recommendations for the diagnosis and management of Alport syndrome in children, adolescents, and young adults-an update for 2020. Pediatr Nephrol. 2021 Mar;36(3):711-719. doi: 10.1007/s00467-020-04819-6. Epub 2020 Nov 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bardoxolone methyl | Small molecule | 20 mg | — |
| Subject | Bardoxolone methyl | Small molecule | 30 mg | — |